The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study

NCT06378489 | Not Yet Recruiting

• 1 other identifier: 2022-0346-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA). The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant.

Conditions

Endometrial Hyperplasia Without Atypia

Keywords

endometrial hyperplasia without atypia; etonogestrel implant

Outcome Measures

Primary Outcomes (2)

• Rate of (resolution) regression to normal endometrium

  3 months after the insertion of the implant

• Endometrial thickness (by ultrasound)

  Performed by expert sonologist

  At three and six months after insertion of the implant

Interventions

Etonogestrel implant DRUG

The etonogestrel implant will be inserted on the inner side of the non-dominant upper arm of the patient. Three months after insertion, a repeat transvaginal ultrasound will be performed to document endmetrial thickness and an endometrial biopsy will also be done using the Pipelle to document the histology of the endometrium. If the biopsy showed regression of the hyperplasia, the implant will be left in place for a minimum of 12 months until 3 years. If the repeat biopsy showed non-resolution of the hyperplasia, the patient will be referred to a gynecologic oncologist for further management

Also known as: Implanon NXT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women aged 18 years old to perimenopause who present with or without abnormal uterine bleeding and who have an endometrial biopsy result which shows endometrial hyperplasia without atypia

You may qualify if:

• women aged 18 years old to perimenopause who present with or without abnormal uterine bleeding and who have an endometrial biopsy result which shows endometrial hyperplasia without atypia
• women willing to have the etonogestrel implant (Implant NXT) for the duration of treatment (6-12 months)
• women who wish to retain their uterus

Sponsors & Collaborators

• University of the Philippines: lead
• Organon: collaborator

MeSH Terms

Interventions

etonogestrel

Study Officials

• Patrick Jose D Padilla, MD

  Philippine General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette Ann S Alcazaren, MD

CONTACT

639178108864; bsalcazaren@up.edu.ph

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: June 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04